Junkfood Science Exclusive: “What if you could pop a pill and lose weight?”
©Sandy Szwarc 2006CBS Evening News publicized just such a “magic pill” that’s already available in
The CBS Early Morning Show followed up with an interview of one of the diet doctors who had participated in the pharmaceutical company’s trials, Dr. Lou Aronne, director of the
Within hours, media across the country headlined Miracle Pill May Help Trim Fat, which Google documented in pages of links like this:
'Miracle Pill' May Help Trim Fat
... "I'm not going to be fat and 60. I want to be slim and 60.". The pill is called Rimonabant and is sold in
'Miracle Pill' May Help Trim Fat
WJZ, MD - 8 hours ago
... "I'm not going to be fat and 60. I want to be slim and 60.". The pill is called Rimonabant and is sold in
'Miracle Pill' May Help Trim Fat
CBS 5, CA - 8 hours ago
... "I'm not going to be fat and 60. I want to be slim and 60.". The pill is called Rimonabant and is sold in
'Miracle Pill' May Help Trim Fat
CBS4Boston,
... "I'm not going to be fat and 60. I want to be slim and 60.". The pill is called Rimonabant and is sold in
'Miracle Pill' May Help Trim Fat
CBS 11, TX - 8 hours ago
... "I'm not going to be fat and 60. I want to be slim and 60.". The pill is called Rimonabant and is sold in
'Miracle Pill' May Help Trim Fat
cbs4denver.com, CO - 8 hours ago
... "I'm not going to be fat and 60. I want to be slim and 60.". The pill is called Rimonabant and is sold in
'Miracle Pill' May Help Trim Fat
... "I'm not going to be fat and 60. I want to be slim and 60.". The pill is called Rimonabant and is sold in
'Miracle Pill' May Help Trim Fat
... "I'm not going to be fat and 60. I want to be slim and 60.". The pill is called Rimonabant and is sold in
'Miracle Pill' May Help Trim Fat
CBS 5 -
... "I'm not going to be fat and 60. I want to be slim and 60.". The pill is called Rimonabant and is sold in
If it all sounds a bit too wonderful, sort of like those gushing weight loss infomercials, you’re right to suspect that there is more to this story we are not hearing. In fact, that was exemplified when no publication in the country queried with this article would dare publish this information. What is of serious concern for this medical professional is just how little is known about this pill; the only clinical evidence is short-term and much less impressive than the public is being led to believe; its new mechanism of action works on the central nervous system, with potentially far-reaching ramifications; and what evidence is available gives every indication of a time bomb far worse than any of the weight loss drugs to date...
Several things were notably absent from the news story, according to Acomplia Report of Medical Week, an independent medical newsletter that’s been following Acomplia’s development for years. Viewers weren’t given information on how much weight she’d lost, the side effects or long-term complications of this new drug. Interestingly, the only dieter interviewed on the news also happened to be the patient acting as a spokesperson, appearing in the drug company’s news conference.
Incentives
Since the world’s third largest pharmaceutical company, Sanofi-Synthelabo (now Sanofi-Aventis), began animal testing of rimonabant in 1996, an intense campaign has unfolded, creating a huge buildup that was supposed to have culminated in FDA approval this fall. Sanofi has drawn criticism from the medical community for releasing drug information to the media and financial investment communities, and at industry conferences, rather than in peer-reviewed medical journals where the data can be carefully reviewed. Through company-sponsored doctor educational programs and conferences, Sanofi has also been laying the groundwork to create acceptance of a new disease, the “metabolic syndrome:” a range of laboratory findings that Acomplia is said to treat.
The market potential is huge, with some forecasts predicting peak sales of $5 billion. While the drug has been introduced in six European countries, with 3-month sales early this fall of $14 million, the really big money is in the U.S., which Business Week reports is expected to account for two-thirds of the potential profit base. They also report that troubles have been mounting for Sanofi and the company is “under intense pressure to get Acomplia into the U.S. market — fast:”
One of its newer drugs—antibiotic Ketek—is under intense scrutiny from the U.S. Food & Drug Administration after it was linked to a dozen cases of acute liver failure, including four deaths. The drug also is at the center of a U.S. congressional investigation into allegations that it was approved despite the FDA's own findings that a key study contained fraudulent information.
The clinical trial evidence — weight loss unremarkable
The latest results of the company’s clinical trial for FDA approval — RIO-North America — were recently published and the results were decidedly less “wonderful” than we heard in the news.
This was a randomized, double-blind, placebo-controlled Phase III drug trial of 3,045 healthy adults. There were two treatment groups, one receiving a lower dose (5mg) and one receiving the full, higher dose (20mg). They were all also put on a low-calorie diet, cutting about 600 calories a day. After one year, those on the highest dose had lost 14 pounds, versus 4 pounds in the placebo group — a 10 pound difference. [If you believe the theories of calories in - calories out and that you lose one pound for every 3500 calories less you eat, the treatment group even without the pill “should” have lost 63 pounds after a year! Just goes to show....]
At the end of the first year, half of the treatment group was put on a placebo to see if they would maintain their weight loss — they didn’t. At the end of the second year, they had regained their weight and were nearly identical to the people who’d been taking the placebo the entire time. At the end of the second year, 40% of those who had continued to take the high-dose had maintained “a weight loss of 5% or greater” compared to 19% of the placebo group.
The weight loss demonstrated in the RIO-Europe Study was similar to the North American limb of the clinical trials: 19 pounds for the 20 mg treatment group and 8 pounds for the placebo group — a difference of 11 pounds.
So, by taking this pill for two years, along with dieting, you could lose an additional 10-11 pounds more than if you hadn’t taken the pill. This small weight loss is never going to make any “obese” person slim. And clearly, that’s not the “miracle weight loss” many believe is being offered.
Complications
The FDA, however, has postponed its approval until next year, requesting more information. Sanofi is not disclosing the FDA’s concerns but they aren’t difficult to surmise. Given how this drug is supposed to work, the side effects being reported may not be as benign as they seem and there are worrisome indications of serious potential problems.
A point to remember with pre-approval drug trials is that the participants differ from the general population. Researchers carefully screen people to include only those without any health problems, in order to minimize adverse reactions and help put the best light on the drug in development. So any complications that are reported deserve close attention. The only clinical evidence on actual people we have are the company’s drug trials where the pills were given to a few thousand people. We don’t know what will happen when it’s given to a million people, all with a variety of conditions and many taking other medications. Many complications won’t appear during short-term trials. Certainly weight loss drugs have had a less than exemplary track record, as their most serious risks came to public light after their release. And too late for many.
The RIO-North America researchers reported that side effects were mild and that the most significant one was nausea in about 11% of the treatment group, versus 6% in the placebo group. But one might rightly suspect that the side effects were considerably more significant than they have indicated because, despite the fact these participants were highly motivated to be part of a miracle new weight loss drug trial, more than half had dropped out after just one year and another 23% of the remaining treatment group during the second year! So the clinical trials have only told us the effects on far fewer than half of the people in the study.
According to the doctors at Medical Week, the most comprehensive review of Acomplia’s side effects available to date were presented as part of the European approval process by the European Medicines Agency. They reported only 15.7% of patients had adverse reactions, but upper respiratory tract infections and nausea were “very common” (more than 1 in 10). And “common” (between 1 and 10 per 100) were: gastroenteritis, depression, anxiety, sleep disorders, memory loss, dizziness, sciatica, diarrhea, vomiting, skin problems, muscle cramps and spasms, fatigue, falls and joint sprains and tendonitis.
It is also noteworthy that despite the trial participants being carefully screened for any hint of psychiatric problems, there were nearly three times more cases of psychiatric disorders developing among the 20mg treatment group, as compared to the placebo. And doctors at the VU University Medical Cantre in Amsterdam reported in 2004 that within months of starting the pill, a healthy 46-year old woman developed multiple sclerosis. That certainly does not prove that the pill was the cause, but we’ll look in a minute at why this finding is especially troubling.
In contrast to what was seen on television here in America, a report last month of British users gave a different perspective of patient experiences:
“I went to my GP (general practitioner) because my usually lovely wavey hair had become thin and lifeless. I had black bags under my eyes and began getting really bad hot flushes five or six times a day. I think I aged 10 years in 8 weeks....My GP took one look at me and told me to stop taking it immediately.”
“The worst thing has been the anxiety, waking up feeling as though something really terrible has happened and not being able to shake the feeling all day. Being really tired and wanting to just lie down and sleep... I have been off them for 2 weeks and I still feel ill.”
“I experienced the hair loss, the upset tum, the dizzyness (I was misjudging spaces and walking into door frames) persistent crying (or feeling like crying) and the cravings. To be honest I flushed them down the loo...I feel much better but it took several weeks to get back to normal.”
A glance to the future?
Whenever we take a drug for the side effects we want, we have to weigh all of the other side effects that come along for the ride that we may not want. Media and researchers give the public a very simple explanation for how this drug supposedly works, equating it with just blocking those marijuana munchies. But it is not that simple.
The drug blocks “cannabinoid-1 receptors,” which allow us to experience the pleasures of eating, but also to feel other sensations of pleasure and joy. These receptors are also found throughout our central and peripheral nervous system and reproductive system. They are involved in maintaining not just our eating, but also reproduction, relaxation, sleep, our emotions and cognitions, and learning. They regulate all of our body systems, said Robert Melamede, PhD, of the University of Colorado, Colorado Springs, in a comprehensive review of the scientific evidence on cannabinoids. Laboratory and animal studies indicate they appear to play a role in:
·reducing inflammation, auto-immune diseases and other immune responses where tissue damage is involved, such as multiple sclerosis, arthritis, Crohn’s disease and diabetes
·defending against a number of neurological degenerative diseases and helping to protect the brain after head injury or stroke
·reducing spasticity
·regulating body temperature
·inhibiting the growth of types of cancer cells, such as in leukemia, lymphoma, skin, breast, prostate, lung, thyroid and colorectal cancers
·reducing nausea and vomiting
·forgetting painful memories and fears
·promoting mental stability
·regulating cardiac rhythms and protecting the heart from oxygen deprivation
·inhibiting the action of a family of enzymes needed to metabolize a variety of prescription drugs
·fertility
“The capacity of cannabinoids to down-regulate a spectrum of auto-immune diseases should serve as a warning against the long term use of CB1 inhibitors for weight control,” said professor Melamede. With this knowledge, the potential significance of that 2004 report of a healthy woman suddenly developing multiple sclerosis is more explicit. “Many of the biochemical imbalances that cannabinoids protect against are associated with aging,” he reported. While there is no clinical trial evidence examining long-term complications of taking this pill, the available experimental and animal studies offer some very worrisome and far-reaching possibilities.
Commentary: It is tragic that we’ve grown so afraid to let ourselves enjoy eating and afraid to accept our natural and varied body sizes, that we would consider taking a pill that could not only jeopardize our health, but eliminate from our lives all pleasure and feelings of exhilaration and happiness. With two-thirds of the population being targeted for this pill, will the risks and benefits and the possible consequences be carefully considered - or even made known - before people rush to try it? What might happen when so many people find themselves living joyless lives and possibly unable to feel happiness, finding no meaning or significance to life, not feeling, and simply not caring about anything anymore? What will become of our creativity and joys of creating beauty in the world? What might be the costs for society in rates of depression, stress disorders, divorce, school drop-out, reduced work productivity and suicide?
And all to lose a few pounds. Nothing better demonstrates the insanity of all of this.
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